Senior Validation Engineer

Hace 10 horas

ciudad juárez, chihuahua, México BEPC Inc. - Business Excellence Professional Consulting Jornada completa

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BEPC has an open position in the Ciudad Juárez area for a Senior Validation Engineer to join our fast-growing team of consultants.

Provide technical engineering support for validation activities, including writing and executing Installation Qualification (IQ) protocols, and supplying data for validation completion reports.
Write and execute Operational Qualification (OQ) protocols and provide supporting data for completion reports.
Write and execute Performance Qualification (PQ) protocols and provide supporting data for completion reports.
Develop and execute Computer System Validation (CSV) protocols.
Develop and execute Total Maintenance Validation (TMV) protocols.
Write and execute SAT (Site/Factory Acceptance Testing) validation protocols and provide data for completion reports.
Conduct experiments during the pre-validation phase and perform additional experiments as required.
Ensure all assigned validation activities are completed on time and in compliance with current requirements and Good Manufacturing Practices (GMP).
Demonstrate strong knowledge of validation processes, GMP, and Good Documentation Practices (GDP).
Execute validation activities, including the creation of calibration and preventive maintenance documentation and records.

Bachelor’s degree in Engineering (Master of Science preferred).
4–6 years of experience in the manufacturing industry and/or 5–6 years of experience in the medical device industry.
Strong presentation skills when working with teams and clients.
Solid experience developing factorial experiments (Design of Experiments – DOE).
Extensive knowledge of Lean methodologies.
Intermediate knowledge of Six Sigma, DMAIC, and Kaizen.
Intermediate knowledge of Project Management principles.
Strong background in statistics.

Seniority level: Mid-Senior.

Employment type: Contract.

Job function: Engineering and Manufacturing.

Industries: Manufacturing, Medical Equipment Manufacturing, and Business Consulting & Services.